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Adjuvant Olaparib BC
- 1. Original Article Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer Andrew N.J. Tutt, M.B., Ch.B., Ph.D., Judy E. Garber, M.D., M.P.H., Bella Kaufman, M.D., Giuseppe Viale, M.D., Debora Fumagalli, M.D., Ph.D., Priya Rastogi, M.D., Richard D. Gelber, Ph.D., Evandro de Azambuja, M.D., Ph.D., Anitra Fielding, M.B., Ch.B., Judith Balmaña, M.D., Ph.D., Susan M. Domchek, M.D., Karen A. Gelmon, M.D., Simon J. Hollingsworth, Ph.D., Larissa A. Korde, M.D., M.P.H., Barbro Linderholm, M.D., Ph.D., Hanna Bandos, Ph.D., Elżbieta Senkus, M.D., Ph.D., Jennifer M. Suga, M.D., Zhimin Shao, M.D., Andrew W. Pippas, M.D., Zbigniew Nowecki, M.D., Ph.D., Tomasz Huzarski, M.D., Ph.D., Patricia A. Ganz, M.D., Peter C. Lucas, M.D., Ph.D., Nigel Baker, M.Sc., Sibylle Loibl, M.D., Ph.D., Robin McConnell, M.Sc., Martine Piccart, M.D., Ph.D., Rita Schmutzler, M.D., Dr.Med.Habil., Guenther G. Steger, M.D., Joseph P. Costantino, Dr.P.H., Amal Arahmani, Ph.D., Norman Wolmark, M.D., Eleanor McFadden, M.A., Vassiliki Karantza, M.D., Ph.D., Sunil R. Lakhani, M.D., Greg Yothers, Ph.D., Christine Campbell, M.Sc., Charles E. Geyer, Jr., M.D., for the OlympiA Clinical Trial Steering Committee and Investigators N Engl J Med Volume 384(25):2394-2405 June 24, 2021
- 2. Study Overview • Among patients who had mutations in BRCA1 or BRCA2 and were at high risk for disease progression, those who were assigned to a year of olaparib adjuvant therapy had 3-year invasive disease–free survival of 86%, as compared with 77% among those who were assigned to placebo. • Few patients stopped olaparib owing to side effects.
- 3. Kaplan–Meier Estimates of Survival. Tutt ANJ et al. N Engl J Med 2021;384:2394-2405
- 4. Subgroup Analysis of Invasive Disease–free Survival. Tutt ANJ et al. N Engl J Med 2021;384:2394-2405
- 5. Demographic and Disease Characteristics of the Patients at Baseline. Tutt ANJ et al. N Engl J Med 2021;384:2394- 2405
- 6. Adverse Events According to Grade. Tutt ANJ et al. N Engl J Med 2021;384:2394-2405
- 7. Summary of Adverse Events in the Safety Analysis Set. Tutt ANJ et al. N Engl J Med 2021;384:2394-2405
- 8. Conclusions • Among patients with high-risk, HER2-negative early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, adjuvant olaparib after completion of local treatment and neoadjuvant or adjuvant chemotherapy was associated with significantly longer survival free of invasive or distant disease than was placebo. • Olaparib had limited effects on global patient-reported quality of life.
Editor's Notes
- Figure 1 Kaplan–Meier Estimates of Survival. In accordance with the standardized definitions for efficacy end points (STEEP) system, the primary end point of invasive disease–free survival (Panel A) was defined as the time from randomization until the date of one of the following events: ipsilateral invasive breast tumor, locoregional invasive disease, distant recurrence, contralateral invasive breast cancer, second primary invasive cancer, or death from any cause. Data for patients without a documented event of invasive disease or death were censored at the date they were last known to be disease-free. Distant disease–free survival (Panel B) was defined as the time from randomization until documented evidence of first distant recurrence of breast cancer or death. Distant recurrence includes the following events: distant recurrence (metastatic breast cancer that has either been biopsy confirmed or radiologically diagnosed as recurrent invasive breast cancer); death attributable to any cause, including breast cancer, nonbreast cancer, or unknown cause; and second primary nonbreast invasive cancer. Evidence of distant recurrence requires either radiologic examination or histopathological confirmation by biopsy. Overall survival (Panel C) was defined as the time from the date of randomization until death due to any cause; the P value for the boundary for significance in this prespecified event-driven interim analysis was less than 0.01. For invasive disease–free survival and distant disease–free survival, 99.5% confidence intervals are shown for the hazard ratios because a P value of less than 0.005 is required to indicate statistical significance for these end points. Similarly, the 99% confidence interval is shown for the hazard ratio for overall survival because a P value of less than 0.01 is required to indicate statistical significance for overall survival. On the basis of the pooling strategy for stratification factors described in Section 3.4 in the Supplementary Appendix, both the Cox model hazard-ratio estimation and the log-rank test were performed with hormone-receptor status as the single stratification factor. The event-free rates at 12, 24, and 36 months in each group are displayed above and below the curves.
- Figure 2 Subgroup Analysis of Invasive Disease–free Survival. The solid vertical line indicates the overall hazard-ratio estimate, and the dashed vertical line indicates a hazard ratio of 1.00, as recommended by Cuzick.23 The size of the blue squares corresponds to the number of events contributing to the estimate of the treatment effect. Even without correcting for multiple comparisons, none of the tests for heterogeneity reached statistical significance. BRCA mutation data reflect central Myriad testing results only. The CPS+EG score is a staging system for disease-specific survival among patients with breast cancer treated with neoadjuvant chemotherapy (NACT).20 This incorporates pretreatment clinical stage, estrogen-receptor status, nuclear grade, and postneoadjuvant chemotherapy pathological stage. Patients who were enrolled had scores ranging from 2 to 6, with higher scores indicating worse prognosis. The prespecified subgroup analysis of the CPS+EG score in patients with previous NACT was performed in all the patients who had received NACT, whether they had hormone-receptor–positive (HR+) disease or triple-negative breast cancer (TNBC). ACT denotes adjuvant chemotherapy, HER2 human epidermal growth factor receptor 2, and NC not calculated.
- Table 1 Demographic and Disease Characteristics of the Patients at Baseline.
- Table 2 Adverse Events According to Grade.
- Table 3 Summary of Adverse Events in the Safety Analysis Set.